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Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis


, : Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. New England Journal of Medicine 356(18): 1809-1822

BACKGROUND:A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.METHODS:In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.RESULTS:Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).CONCLUSIONS:A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures.


Accession: 013259105

PMID: 17476007

DOI: 10.1056/NEJMoa067312

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Related references

Carmona, R.; Adachi, R., 2009: Treatment of postmenopausal osteoporosis, patient perspectives - focus on once yearly zoledronic acid. Oral bisphosphonates are of proven efficacy in preventing fractures in postmenopausal osteoporosis. However, poor adherence limits their real-world efficacy and clinical utility. Zoledronic acid (ZOL) is a potent bisphosphonate administered by ann...

Najib, M.A.; Aziz, I., 2007: Yearly zoledronic acid in postmenopausal osteoporosis. New England Journal of Medicine 357(7): 713; Author Reply 714-5

Woodis, C.Brock., 2008: Once-yearly administered intravenous zoledronic acid for postmenopausal osteoporosis. OBJECTIVE: To review studies that investigated the use of once-yearly administered intravenous zoledronic acid for the treatment of postmenopausal osteoporosis.DATA SOURCES: Searches of MEDLINE (1966-February 2008) and EMBASE (1974-February 2008)...

Migliorati, C.A., 2009: Low incidence of osteonecrosis of the jaw in postmenopausal women with osteoporosis taking zoledronic acid once yearly. Journal of Evidence-Based Dental Practice 9(1): 13-15

Johnson, B.E., 2007: A once-yearly IV infusion of zoledronic acid prevented fractures in postmenopausal women with osteoporosis. Acp Journal Club 147(2): 31-31

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Delmas, P.D.; Munoz, F.; Black, D.M.; Cosman, F.; Boonen, S.; Watts, N.B.; Kendler, D.; Eriksen, E.F.; Mesenbrink, P.G.; Eastell, R., 2009: Effects of yearly zoledronic acid 5 mg on bone turnover markers and relation of PINP with fracture reduction in postmenopausal women with osteoporosis. In patients with osteoporosis treated with antiresorptive agents, reduction in bone turnover explains much of the observed fracture risk reduction. Lower levels of bone turnover markers (BTMs) appear to be associated with a lower risk of fracture...